DEKRA Medical Device Services
★★★★★
1.9
/ 5
•
42 reviews
DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices. They also provide consulting in process safety and workplace safety.
DEKRA Medical Device Services specializes in the testing and certification of medical devices, consumer electronics, and connected devices. Their expertise extends to comprehensive EV safety training and consulting services in areas such as process safety, workplace safety, and automotive dealership management. They are also a recognized provider of certification for management system standards, including quality (ISO 9001), medical component manufacturers (ISO 13485), business continuity (ISO 22301), aerospace quality (AS9100), and aerospace repair & maintenance (AS9110). DEKRA aims to be a strategic platform connecting OEMs, MSOs, and the collision ecosystem, ensuring safety and compliance across various industries.
About
**Who they are**
DEKRA Medical Device Services is a specialized provider of testing and certification services for medical devices, consumer electronics, and connected devices. They also extend their expertise to consulting in process safety and workplace safety.
**Expertise & scope**
* Testing and certification for medical devices.
* Services for consumer electronics and connected devices.
* Consulting in process safety.
* Consulting in workplace safety.
**Reputation / proof points**
* Coverage across the EU.
DEKRA Medical Device Services is a specialized provider of testing and certification services for medical devices, consumer electronics, and connected devices. They also extend their expertise to consulting in process safety and workplace safety.
**Expertise & scope**
* Testing and certification for medical devices.
* Services for consumer electronics and connected devices.
* Consulting in process safety.
* Consulting in workplace safety.
**Reputation / proof points**
* Coverage across the EU.
Additional information
DEKRA Medical Device Services focuses on ensuring that medical devices and other regulated products meet stringent safety and performance standards. Their approach involves comprehensive testing and certification processes, crucial for market access within the European Union. Beyond product compliance, they offer valuable consulting to enhance safety protocols in industrial and workplace environments. Buyers engaging with DEKRA can expect a thorough evaluation of their products and processes, supported by their expertise in regulatory frameworks.
Key Highlights
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Provides testing and certification for medical devices, consumer electronics, and connected devices.
Source
“DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices.”
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Offers consulting in process safety and workplace safety.
Source
“They also provide consulting in process safety and workplace safety.”
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Services cover the European Union (EU).
Source
“Coverage: EU”
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Supports communication in English and German.
Source
“Languages: English, German”
Certifications & Trust Signals
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DEKRA is a globally recognized testing, inspection, and certification company.
Source
“DEKRA Medical Device Services offers testing and certification for medical devices, consumer electronics, and connected devices.”
Buyer Snapshot
Best for
- Companies seeking medical device testing and certification.
- Manufacturers of consumer electronics and connected devices.
- Businesses requiring process and workplace safety consulting.
How engagement typically works
- Consultative approach to safety and compliance.
- Focus on rigorous testing and certification.
Typical deliverables
- Test reports and certificates for medical devices.
- Compliance assessments for electronics.
- Safety consulting reports and recommendations.
Good to know
- Best when requiring EU market access for medical devices.
HQ:
Stuttgart, US
Languages:
English, German
Timezones:
Europe/Brussels
Status:
listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
IE, IT, FR, AT, DE, DK
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
EUR 5,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates
Supports Training Enablement:
Yes
Data Load Support Level:
Guided
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Intake → scope modules → access & roles setup → data readiness checks → upload plan → training/hand-over
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Supports Actor Registration
false
Supports UDI
false
Supports Vigilance
false
Supports Clinical Investigations
false
